The Impact of Local Analgesia for Postoperative Analgesia in Posterior Thoracolumbar Operation

Pain Treatment in Posterior Thoracolumbar Operation a Randomized Study to Assess the Effect of Local Analgesia After Operation

Posterior thoracolumbar operation always chooses general anesthesia. Due to surgical trauma and rich periosteum and joint capsule innervation, patients after general anesthesia immediately feel acute pain.The use of appropriate postoperative analgesia in patients with thoracolumbar surgery is beneficial to postoperative recovery. Infusions of local anaesthetic via multilumen catheters that deliver directly to wound sites have been used for postoperative analgesia in procedures. Reducing the morbidity from both pain and nausea will make the mode of analgesia a better tolerated and more palatable option for patients. The aim of this study is to examine the effects of using local anaesthetic infusion catheters following posterior thoracolumbar surgery, and compares the outcomes of patients managed using intravenous analgesia pump infusion of systemic opioids.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: local; Drug: 0.33% ropivacaine 250ml; Other: intravenous; Drug: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.

Detailed Description

All 71 adult patients were prospectively included and randomized to either the local (L) group (n=35) or the intravenous (V) group (n=36) by using a random number table: the test group were treated with local analgesia infusion pump of 0.33% ropivacaine through the wound for postoperative analgesia, while the control group were treated with intravenous analgesia pump infusion of flurbiprofen axetil,palonosetron, pentazocine. At 2, 4, 6, 12, 24, 36, 48 hours after operation, postoperative pain visual analogue scale(VAS) scores and sedation Ramsay scores were used to evaluate the level of pain and sedation, and investigators documented the comprehensive evaluation of patients with pain control system, and the incidence of adverse reactions. At 24, 48 hours investigators observed the wound whether inflammation and exudation or not, and the removal of penetration catheter sent to clinical laboratory for bacterial culture. Investigators also recorded the length of time to discharge and called to ask pain conditions at the first 3 months.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510010
      • Guangzhou Military Region General Hospital, Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ASA Ⅰ ~ Ⅱ patient undergoing elective posterior thoracolumbar operation
2. between 18 and 70 years of age

Exclusion Criteria:

1. A history of cardiopulmonary disease, liver and kidney dysfunction, abnormal coagulation
2. Preoperative use of analgesic drugs
3. A allergy history of ropivacaine and polyurethane material

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Local; This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.	Other: local; This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.; Drug: 0.33% ropivacaine 250ml
Active Comparator: intravenous; This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.	Other: intravenous; This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.; Drug: flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	Up to 48 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.	48 hours postoperation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sedation	At 2, 4, 6, 12, 24, 36, 48 hours after operation,sedation Ramsay scores are used to evaluate the level of sedation.	48 hours postoperation
comprehensive evaluation	Investigators document the comprehensive evaluation of patients with pain control system,including the incidence of adverse reactions.	48 hours postoperation

Collaborators and Investigators

• Sponsor: Guangzhou General Hospital of Guangzhou Military Command

Publications and helpful links

General Publications

• Jirarattanaphochai K, Jung S, Thienthong S, Krisanaprakornkit W, Sumananont C. Peridural methylprednisolone and wound infiltration with bupivacaine for postoperative pain control after posterior lumbar spine surgery: a randomized double-blinded placebo-controlled trial. Spine (Phila Pa 1976). 2007 Mar 15;32(6):609-16; discussion 617. doi: 10.1097/01.brs.0000257541.91728.a1.
• Mekawy N M, Badawy S S I, Sakr S A. Role of postoperative continuous subfascial bupivacaine infusion after posterior cervical laminectomy: Randomized control study. Egyptian J Anaesth, 2012, 28(1): 83-88.
• Aguirre J, Baulig B, Dora C, Ekatodramis G, Votta-Velis G, Ruland P, Borgeat A. Continuous epicapsular ropivacaine 0.3% infusion after minimally invasive hip arthroplasty: a prospective, randomized, double-blinded, placebo-controlled study comparing continuous wound infusion with morphine patient-controlled analgesia. Anesth Analg. 2012 Feb;114(2):456-61. doi: 10.1213/ANE.0b013e318239dc64. Epub 2011 Nov 10. Erratum In: Anesth Analg. 2013 Jun;116(6):1394.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Estimate): May 2, 2014
• Last Update Submitted That Met QC Criteria: May 1, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Postoperative; Ropivacaine; Local analgesia system; Analgesic efficacy after operation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Serotonin Agents; Serotonin Antagonists; Adjuvants, Anesthesia; Narcotic Antagonists; Anesthetics, Local; Serotonin 5-HT3 Receptor Antagonists; Palonosetron; Ropivacaine; Flurbiprofen; Flurbiprofen axetil; Pentazocine
• Other Study ID Numbers: local anaesthetic